Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children

Phase 4

• Conditions: Uncomplicated Malaria
• Interventions: Drug: Oral quinine; Drug: artemether-lumefantrine

• Registration Number: NCT00540202
• Lead Sponsor: Makerere University

Brief Summary

We will test the hypothesis that there is a difference in effectiveness of oral quinine in comparison to artemether Lumefantrine in the treatment of uncomplicated malaria in children.

Detailed Description

This study will be designed as an open randomized effectiveness study assessing the parasitological and clinical cure rates and adherence to oral quinine monotherapy in comparison to artemether-Lumefantrine. We will also describe some of the adverse events to the two drugs.The measurements will include age, sex, weight, hemoglobin levels on days 0, 7, 14 and 28, parasite density on days 0, 7, 14 and 28 and clinical examination findings. Adverse events will also be documented

Study Timeline

• Study Start: 2007-09
• Status Verified: 2007-10
• Study First Submitted: 2007-10-04
• Study First Submitted QC: 2007-10-04
• Last Update Submitted: 2007-10-04
• Study First Posted: 2007-10-05
• Last Update Posted: 2007-10-05
• Study Completion: 2008-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

1. Aged between 6 and 59 months of age seen at the assessment centre during the study period
2. With fever defined as axillary temperature ≥37.5 °C or history of fever in the past 24 h
3. With a microscopically confirmed monoinfection of Plasmodium falciparum
4. Able to tolerate oral therapy,
5. Whose parents/guardians have provided written informed consent.

Exclusion Criteria

1. Children with a history of allergy to quinine, artemether-Lumefantrine or milk.
2. Evidence of severe malaria.
3. Residence at more than 20km from the health clinic.
4. Evidence of a significant concomitant febrile illness that would require hospitalization or chronic medical illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1.Oral quinine	Oral quinine	Patients will be given oral quinine at the dose of 10mg/kg 8 hourly for 7 days
2. Coartem	artemether-lumefantrine	Tablets

Primary Outcome Measures

Name	Time	Method
1. PCR adjusted parasitological cure rate on day 28. 2. Clinical cure rates on day 28.	28 days

Secondary Outcome Measures

Name	Time	Method
1. Fever clearance time assessed by self report. 2. Hemoglobin changes on day 0, 7, 14 and 28. 3. Safety profiles. 4. Adherence: measured by patient report and pill count on day 3 for the artemether-Lumefantrine group and day 7 for the quinine group.	28 days

Trial Locations

Locations (1)

Mulago National Referral Hospital; 🇺🇬 Kampala, Central, Uganda